viernes, 12 de febrero de 2016

Drug Information Update - FDA alerts compounding pharmacies of a nationwide voluntary recall of SyrSpend SF and SyrSpend SF Grape suspending agents from Fagron Inc., due to microbial contamination with yeast

FDA Division of Drug Information: Know the Moment It Happens
The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration is alerting compounding pharmacies of the voluntary recall of certain lots of SyrSpend SF and SyrSpend SF Grape suspending agents used in compounding of various oral liquid drug products, due to the presence of yeast (Candida galli).
The SyrSpend SF lots are:
  • 15I21-U01-026920
  • 15J26-U05-027457
  • 15J26-U05-027473
  • 15I21-U01-027370
  • 15J19-U05-027406
The SyrSpend SF Grape lots are:
  • 15G29-U03-025975
  • 15A05-U03-022765
  • 15A05-U06-023277
If an immunocompromised patient or a child with an immature immune system ingests the contaminated product, there is a potential the patient will get an infection for which systemic antimicrobial therapy would be necessary.
FDA recommends that compounders not use the referenced lots of contaminated Syrspend SF and Syrspend SF Grape in compounding drug products for patients.  Compounding pharmacies who have received the referenced lots of Syrspend SF and Syrspend SF Grape flavor should immediately discontinue use, quarantine the products,and return the products to Fagron, Inc.  
FDA is not aware of adverse events reports with patients who may have used the suspending agents. FDA asks compounding pharmacies to report any adverse reactions to the FDA’s MedWatch program: 
For more information, please visit: SyrSpend SF and SyrSpend SF Grape

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